Z-2335-2024Class II

Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069...

Name: Z-2335-2024 Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069...
Creator: MICROspecialties, Inc.
Published: 2024-06-05
License: https://open.fda.gov/license/

Microspecialties LLC / initiated 2024-06-05 / Open, Classified / root cause: sterility

FDA source

MICROspecialties, Inc. began a recall of Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description on 2024-06-05. FDA classified it as Class II and gives the reason as "Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2335-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-05
Posted: 2024-07-11
Recalling firm: Microspecialties LLC
Product: Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Root cause tag: sterility
FDA root cause: Release of Material/Component prior to receiving test results
Action: MICROspecialties issued Voluntary recall for Synergetics Eye Trays letter on 6/3/24 to the Distributor Synergetics. Letter states reason for recall, health risk and action to take: Review: Inventory for affected product codes Communicate with customers impacted by this notice. Segregate and Quarantine all affected product. Utilize return instructions below Disseminate this notice to any customers who may have been affected. Return the below acknowledgement form by Fax to:860-788-2030 Or email to: [email protected] Contact [email protected] for product return instructions. Please return by 6/25/24. For additional information regarding this please contact [email protected].
Quantity in commerce: 780 units
Distribution: MO
Product codes and lots: UDI 10841305101125 LOT: P62764965R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2335-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2333-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2334-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2335-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11
Z-2336-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-11

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)